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Rentschler Biopharma

CDMO delivering biopharmaceutical development and manufacturing

Senior Director Quality Assurance & QP

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeLaupheim, GermanyNo salary listed

About the Job

Requirements

  • Pharmacy licensure and qualification as a Qualified Person under §14 AMG / EU Directive.
  • Several years of experience in biopharmaceutical drug-substance manufacturing and batch release.
  • Excellent knowledge of international pharmaceutical requirements and regulations, including AMG, AMWHV, EU-GMP, US CFR, ICH, and FDA regulations.
  • Long-standing professional experience and in-depth expertise in the relevant field.
  • Several years of disciplinary leadership experience, including motivating and developing employees.
  • Experience leading large projects.
  • Business-fluent German and English, spoken and written.
  • Very good knowledge of project management methods.
  • Entrepreneurial thinking and economic, strategic, and solution-oriented judgment.
  • Ability to develop effective strategies, drive innovation, lead by example, and give clear directions.
  • Experience conducting risk and issue management, including strategies for identifying, tracking, and mitigating risks.

Responsibilities

  • Take overall responsibility for planning, preparing, conducting, and following up on self-inspections, customer audits, and regulatory inspections, both on-site and remotely; ensure GMP-compliant responses to identified deficiencies and monitor inspection-specific KPIs.
  • Act as the main contact for authorities in handling GMP requests during authorization procedures.
  • Coordinate and process quality questions in customer questionnaires.
  • Lead Supplier Quality Management, including risk-based qualification and monitoring of suppliers, service providers, and contract laboratories; plan and conduct global supplier audits, including in the United States and Asia; lead the cross-functional assessment of Supplier Change Notifications; and create and maintain Quality Agreements.
  • Assess materials used directly or indirectly in the process for regulatory compliance and criticality to the manufacturing process and patient safety.
  • Approve raw materials and production materials for ordering in the SAP material master system.
  • Oversee complaint management through the SCAR process, coordinating across Procurement and specialist departments.
  • Lead and develop a team of approximately 10 employees, including resource planning, KPI management, and continuous process improvement.
  • Manage interfaces with Production, MSAT, QC, Regulatory Affairs, Logistics, Procurement, and Business Development/Project Management.
  • Ensure compliance with and development of SOPs, quality processes, and electronic quality management systems.
  • Review general and/or project-specific risk analyses of regulatory requirements for process materials.
  • Release active-substance batches manufactured at the site for shipment and further processing.
  • Support Quality Assurance leadership in preparing high-level customer and Quality Board meetings and in process-optimization projects.

Desired Qualifications

  • Experience in a CDMO environment and working with international customers.

About the Company

Rentschler Biopharma

CDMO delivering biopharmaceutical development and manufacturing

What the company does: Rentschler Biopharma provides contract development and manufacturing services for biopharmaceuticals, helping other pharmaceutical companies develop and produce complex medicines. How its products work: It offers end-to-end services in biopharma development and manufacturing, backed by facilities and staff that design, optimize, and produce biologic drugs at scale for clients, including a major site in Milford, MA that has expanded capacity to serve the international market. How it differs from competitors: It has a long heritage in biopharma, a dedicated CDMO focus since 1997, and a global footprint with a major U.S. site and expanded capacity, positioning itself as a reliable partner for developing and manufacturing complex biologics. What its goal is: To be a trusted partner for pharmaceutical companies by providing development and manufacturing services at scale, supporting clients as they bring biologic medicines to market.

Company size
501-1,000
Company stage
Series A
Total funding
$1.6M
Headquarters
Laupheim, Germany
Founded
1927

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